New · posted Oct 15
Kailera · Pharmaceuticals
Associate Director, Analytical Development and Quality Control
- Remote, US
- Remote
- Full-time
- Director
Open until filled
The role
At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions.
We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.
Additional Information
- This position requires some travel to domestic and international destinations.
- In rare occasions, this position may require working in environments where there may be specific gowning or dress code requirements.
What you need
Required Qualifications
- A bachelor’s degree and 10+ years of experience in the pharmaceutical/biotech industry with experience in late phase drug substance development, NDA submissions, PAI readiness, and commercial launch in accordance with global CMC regulatory filings (IND/NDA/MAA, etc.).
- Or an advanced degree with 5+ years
- Knowledge of peptide chemistry and strong understanding of peptide degradation pathways and impurity control strategy. Experience in the analytical support of drug substance PPQ/Process Validation.
- Demonstrated analytical project leadership and cross-functional team participation.
- Experience in setting commercial specifications.
- Experience in authoring regulatory documents, including NDA experience
- Knowledge and strong understanding of drug development activities with respect to cGMP, quality systems, global regulatory requirements, and USP, EP, JP, and CHP requirements.
- Strong understanding of all applicable ICH guidelines.
- Method validation experience.
- Experience with oversight of the analytical activities at CDMOs and/or CTLs.
- Sound problem-solving skills with technically driven decision-making ability.
- Effective written and verbal communication and interpersonal skills.
- Innovative team-player with high energy for our dynamic company environment.
Education
- A Bachelor’s degree with 10+ years or an advanced degree with 5+ years of relevant experience
- Degree in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, or closely related field.
Preferred Qualificationsnice to have
- Knowledge and experience in analytical development of injectable products, and associated control strategies
- Knowledge and experience in analytical development of small molecules and solid oral dosage forms.
- Successful support of at least one NDA and commercial launch.
- Synthetic peptide manufacturing knowledge.
- Experience with statistics and applying statistics to analytical chemistry.
- Regulatory Inspection experience.
What you'll do
The Associate Director, Analytical Development and Quality Control will support analytical development and QC operations for clinical development and commercialization of Kailera’s pipeline compounds. The individual will provide technical expertise and will work closely with cross-functional stakeholders to ensure end-to-end drug development and manufacturing activities are executed seamlessly and in alignment with the company’s integrated development plans and program timelines.
- Lead analytical development and support QC activities related to the development and commercialization of peptide drug substances..
- Develop and maintain current knowledge in analytical methods and product and process control strategies supporting the peptide drug substance.
- Through our external network, lead the development of analytical methods that support Kailera’s product pipeline, including analytical transfers and troubleshooting in CDMO laboratories.
- Provide input for developing and implementing analytical development strategies, including managing execution of functional activities in support of clinical development, regulatory filings (IND/NDA/MAA), product approvals, and commercialization.
- Author relevant CMC sections to enable global regulatory filings.
- Participate on cross-functional CMC teams for the project(s) assigned to ensure adequate development and execution of CMC plan/strategies as needed.
- Communicate CMC project status to key stakeholders cross-functionally and assist in driving decision-making.
- Collaborate with cross-functional line functions to ensure CMC and program goals are met.
- Travel to CDMOs and other service providers as needed for vendor technology transfers and analytical activities oversight.
Pay and benefits
$155,000 – $190,000 a year
Employer provided$155,000—$190,000 USD
For Full Time Roles: This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.
Comprehensive health coverage
Flexible time off
401(k) match
Monthly wellness stipend
Tuition reimbursement
Annual bonus and equity grants
Equal opportunity, accessibility and legal noticesKailera's statements, word for word
EQUAL EMPLOYMENT OPPORTUNITY INFORMATION
Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.
E-Verify
Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 18% below the US median for Regulatory CMC roles at this level.
This roleEmployer provided
Director roles in the US43 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $155,000 | — | $190,000 |
| All US (middle half) | $190,500 | $210,000 | $244,500 |
This role: Kailera's own published range. Comparisons: the base pay employers published on open Regulatory CMC roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory CMC
The general path across 82 open Regulatory CMC roles on Regulatory Jobs, with the titles they carry most. Not Kailera's own promotion track.
Career resources on Regulatory CMC
Skills DNA
What this role leans on
How many of the posting's 33 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods14
- Collaboration and leadership10
- Regulatory submissions4
- GMP and compliance2
- Validation and qualification2
- Documentation and SOPs1
- Quality systems and risk1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDAFDA process validation guidance(official source, opens in a new tab)Process Validation: General Principles and Practices
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
- FDAFDA NDA(official source, opens in a new tab)New Drug Applications
- USPUSP compendial chapters(official source, opens in a new tab)Bioburden (USP <61>), endotoxin (USP <85>), TOC (USP <643>) and water testing
Company hiring pulse
Kailera on Regulatory Jobs
- 5
- Open roles
- 5
- Distinct roles
- 2
- Locations
By discipline
- Regulatory4 80%
- Quality1 20%
By level
- Director4 80%
- Senior & Principal1 20%
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Associate Director, Analytical Development and Quality Control at Kailera
Open until filled. $155K–$190K a year, employer provided.